The FDA today updated Medtronic’s Class I recall for the company’s SynchroMed II and SynchroMed EL implantable drug pumps, which were designed to locally treat primary or metastatic cancer, chronic pain, and severe spasticity.
The pumps were recalled in 2013 because they unintentionally delivered drugs during the priming bolus procedure and patients were at risk for overinfusion in the cerebrospinal fluid followed by a period of reduced drug delivery.
In October last year, Medtronic said that the SynchroMed II implantable drug pump was linked to more than 100 adverse events including 2 previously unreported deaths.
